Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012Reasons for FDA Delay or Denial of New Drug ApplicationsReasons for FDA Delay or Denial of New Drug Applications
Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE.
Published online January 22, 2014
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